XLO 10-K & 10-Q changes, risk factors and insider trading
Xilio Therapeutics, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1840233 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “We will need to obtain substantial additional capital in the future to finance our operations and complete the development of any current or future product candidates.”
New heading “The recently implemented reverse stock split of our common stock may not achieve the intended benefits and could have a materially adverse effect on the market price of our common stock.”
New heading “Raising additional capital in the future may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to product candidates or our technology. In addition, the issuance of shares of common stock upon the exercise of our outstanding prefunded warrants or common stock warrants will result in immediate and substantial dilution to our existing stockholders.”
New heading “Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug product candidates and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictions.”
Removed heading “Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern. If we are unable to raise sufficient additional capital in the near term, we will need to implement additional cost reduction strategies, which could include delaying, limiting, reducing or eliminating both internal and external costs related to our operations and research and development programs.”
Removed heading “Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to product candidates or our technology.”
Removed heading “Current and future legislation may increase the difficulty and cost for us to obtain reimbursement for any of our candidate products that do receive marketing approval.”
Largest changes
“Given the breadth and depth of changes in data protection obligations, complying with the GDPR’s requirements is rigorous and time intensive and requires significant resources and a review of our technologies, systems and practices, as well as those of any third-party collaborators, service providers, contractors or consultants that process or transfer personal data collected in the European Union. …”see in full comparison
“In addition to our CDMO, WuXi Biologics, some of our other suppliers, vendors and service providers are located in China. Trade tensions and conflicts between the United States and China have been escalating in recent years and, as such, we are exposed to the possibility of supply disruptions and increased costs and expenses in the event of changes to the laws, rules, regulations and policies of the governments of the United States or China, or due to geopolitical unrest and unstable economic conditions. …”see in full comparison
“Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing our product candidates and platform materials, affect the demand for our drug products (if and once approved), the competitive position of our product candidates, and import or export of raw materials and finished product candidate used in our and our collaborators’ preclinical studies and clinical trials, particularly with respect to any product candidates and materials that we import from China, including pursuant to our manufacturing …”see in full comparison
There are a broad variety of data protection laws that are applicable to our activities, and a wide range of enforcement agencies at both the state and federal levels that can review companies for privacy and data security concerns based on general consumer protection laws. The Federal Trade Commission, or FTC, and state attorneys general all are aggressive in reviewing privacy and data security protections for consumers.see in full comparisonIn addition, new laws have been enacted orThere areconsideredalso increased restrictions atboththe federal level relating to transferring sensitive data outside of the United States to certain foreign countries. For example, in 2024, Congress passed H.B. 815, which included the Protecting Americans’ Data from Foreign Adversaries Act of 2024. This law creates certain restrictions for entities that disclose sensitive data, including potential health data, to countries such as China. Failure to comply with these rules can lead to a potential FTC enforcement action. Additionally, the Department of Justice recently finalized a rule implementing Executive Order 14117, which creates similar restrictions related to the transfer of sensitive U.S. data to countries such as China. These data protection laws andstatetransferlevels.restrictions, and others that may pass in the future, may create operational challenges and legal risks for our business. As a result, we will need to seek to ensure our business practices comply with evolving rules and guidance at the federal and state level related to privacy and data security in order to mitigate our risk for any potential enforcement action, which may be costly. In addition, if we are subject to an enforcement action and settlement order, we may be required to adhere to very specific privacy and data security practices or pay fines and adhere to specified compliance requirements, all of which could be costly and adversely impact our business. For example, the FTC has been particularly focused on the unpermitted processing of health and genetic data through its recent enforcement actions and is expanding the types of privacy violations that it interprets to be “unfair” under Section 5 of the FTC Act, as well as the types of activities it views to trigger the Health Breach Notification Rule, which the FTC also has the authority to enforce, and is in the process of developing rules related to commercial surveillance and data security.
“The U.S. government has recently made statements and taken certain actions that may lead to potential changes to U.S. and international trade policies, including imposing several rounds of tariffs and export control restrictions affecting certain products manufactured in China, and most recently, proposing legislation that, if enacted would restrict trade with certain Chinese companies that provide biopharmaceutical research, development, and manufacturing services. Recently both China and the United States have each imposed tariffs indicating the potential for further trade barriers. …”see in full comparison
“Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern. If we are unable to raise sufficient additional capital in the near term, we will need to implement additional cost reduction strategies, which could include delaying, limiting, reducing or eliminating both internal and external costs related to our operations and research and development programs.”see in full comparison
Full comparison: every changed paragraph (421)
We will need to obtain substantial additional capital in the future to finance our operations and complete the development of any current or future product candidates.
As of December 31, 2025, we had cash and cash equivalents of $137.5 million. In the first quarter of 2026, we received net proceeds of approximately $37.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, upon the closing of a follow-on offering of prefunded warrants and a $5.0 million development milestone related to the collaboration agreement with AbbVie Group Holdings Limited, or AbbVie. Based on our current operating plans, we anticipate that our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the end of 2027. This estimate excludes any potential future milestone payments, option-related fees or other contingent payments under our existing collaboration and partnership agreements with AbbVie and Gilead Sciences, Inc., or Gilead, and excludes the potential receipt of up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price. In addition, we have based our estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we anticipate and may need to seek additional capital sooner than anticipated.
Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern. If we are unable to raise sufficient additional capital in the near term, we will need to implement additional cost reduction strategies, which could include delaying, limiting, reducing or eliminating both internal and external costs related to our operations and research and development programs.
As of December 31, 2024, we had cash and cash equivalents of $55.3 million. Based on our current operating plans, we anticipate that our cash and cash equivalents as of December 31, 2024, together with the $52.0 million in upfront payments received in the first quarter of 2025 in connection with our collaboration agreement with AbbVie Group Holdings Limited, or AbbVie, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026. However, since these amounts are not expected to be sufficient to fund our operations for at least twelve months from the date of issuance of the consolidated financial statements included elsewhere in this Annual Report on Form 10-K, there is substantial doubt about our ability to continue as a going concern. Our future capital requirements and the period for which we expect our existing resources to support our operations may vary from what we expect. Our management has developed plans to continue to fund our operations, which primarily consist of raising additional capital through one or more of the following: additional equity or debt financings; additional collaborations, partnerships or licensing transactions; or other sources. However, there can be no assurance that we will be able to complete any such transaction on acceptable terms or otherwise, and we may be unable to obtain sufficient additional capital in the near term.
If we are not able to secure sufficient additional capital, we will need to implement additional cost reduction strategies, which could include delaying, limiting, further reducing or eliminating both internal and external costs related to our operations and research and development programs. If we are unsuccessful in our efforts in the near term to raise additional capital or in the future to engage in one or more other strategic alternatives, we could be required to liquidate, dissolve or otherwise wind down our operations. Furthermore, our cash forecasts are based on assumptions that may prove to be wrong, and we could use our available capital resources earlier than we currently expect. Please see Note 1 to our consolidated financial statements appearing elsewhere in our Annual Report on Form 10-K for additional information on our assessment.
We expect to continue to incur operating losses in connection with our ongoing research and development activities, particularly as we advance our product candidates through clinical trials, maintain the infrastructure necessary to support these activities and incur costs associated with operating as a public company. We do not expect to generate any revenue from the sale of products for a number of years, if at all, and any such revenue will not be realized unless and until we obtain marketing approval for and successfully launch and commercialize a product candidate. If we obtain marketing approval for any current or future product candidates that we develop, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. Some of these expenses may be incurred in advance of marketing approval and could be substantial.
Our future capital requirements, both short-term and long-term, will depend on many factors, includingincluding, but not limited to:
the scope, progress, results and costs of research and development for our current and future product candidates, including our current and planned clinical trials for our clinical-stage product candidates, vilastobart and efarindodekin alfa, and ongoing preclinical development for our current and future product candidates;
our ability to maintain our collaboration and license agreements with AbbVie and Gilead;
the timing and amount of milestones, option-related fees and other contingent payments under our collaboration, license and option agreement with AbbVie for masked immunotherapies and our license agreement with Gilead for efarindodekin alfa, as well as the scope, costs and timing of our development obligations under these agreements;
the potential receipt of up to $36.2 million in additional gross proceeds in the second half of 2026 if all of the outstanding Series C common stock warrants issued in connection with our June 2025 follow-on offering are exercised at their current exercise price of $10.50 per warrant;
our ability to secure additional capital in the future;
the scope, prioritization and number of our research and development programs;
the costs of securing manufacturing materials for use in preclinical studies, clinical trials and, for any product candidates for which we receive regulatory approval, if any, commercial supply;
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property-related claims;
the extent to which we may acquire or in-license other products, product candidates, technologies or intellectual property, as well as the terms of any such arrangements;
the scope, costs, timing and outcome of regulatory review of our product candidates;
the costs and timing of future commercialization activities for any of our product candidates for which we receive regulatory approval;
the amount and timing of revenue, if any, received from commercial sales of any product candidates for which we receive regulatory approval;
general economic conditions, including inflation and the imposition of new or revised global trade tariffs; and the costs of maintaining our operations and continuing to operate as a public company.
WeOur existing cash and cash equivalents will not be sufficient to complete development of any current or future product candidates, and we will require additional capital in the future to sustain our operations. We currently do not have any committed external sources of funds and will be required to obtain further funding in the future through public or private equity offerings, debt, collaborations, licensing arrangements, the conversion of common stock warrants for cash, or other sources. However, adequate additional capital may not be available to us in the future on acceptable terms, or at all. In addition, our ability to raise additional capital may be adversely impacted by potential worsening economic conditions, both inside and outside the United States, including without limitation heightened inflation, capital market volatility, interest rate and currency rate fluctuations, any potential economic slowdown or recession, future pandemics, geopolitical tensions, including trade wars or civil or political unrest, or wars or other armed conflicts. WeOur can give no assurance that we will be ablefailure to secureraise additional capital in the future as and when needed to support our operations, or if such funds are available to us, that such additional funding will be sufficient to meet our needs. These factors raise substantial doubt about our ability to continue as a going concern, and our failure to raise capital, on attractive terms or at all,operations would have a material adverse effect on our business,financial resultscondition, ofour operationsability to develop and financialcommercialize condition.our current and any future product candidates or otherwise pursue our business strategy.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to product candidates or our technology.
Unless and until we can generate a substantial amount of product revenue, we expect to seek additional capital through a combination of public or private equity offerings, debt, collaborations, licensing arrangements or other sources. Our issuance of additional securities, whether equity or debt, or the possibility of such issuance, may cause the market price of our common stock to decline, and our stockholders may not agree with our plans for additional capital or the terms of such capital. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. For example, when we issue shares of common stock upon the exercise of our outstanding prefunded warrants, or if we issue additional shares of our common stock in one or more “at-the-market,” or ATM, offerings, our existing stockholders will suffer dilution. In addition, as a condition to providing additional funds to us, Gilead and AbbVie received, and future investors may receive, rights superior to those of existing stockholders. To the extent that we incur additional indebtedness, we would become obligated to make payments to repay the loan balance with interest. The incurrence of any additional indebtedness would result in additional payment obligations and is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, would be repaid before holders of our equity securities received any distribution of our corporate assets. Additionally, in raising funds through our collaborations and licensing arrangements with third parties, we have had to, and may in the future need to, relinquish valuable rights, partially or fully, to our technologies, future revenue streams, research programs or product candidates and grant licenses on terms unfavorable to us. In addition, securing additional capital would require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.
If in the future we fail to complyregain and maintain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
On April 4, 2025, we received a deficiency letter from the Listing Qualifications Department, or the Nasdaq Staff, of the Nasdaq Stock Market LLC, or Nasdaq, notifying us that, for the last 30 consecutive business days, the bid price for our common stock had closed below $1.00 per share, which is the minimum bid price required to maintain continued listing on the Nasdaq Global Select Market, referred to as the minimum bid price requirement. In accordance with Nasdaq Listing Rules, we had an initial period of 180 calendar days, or until October 1, 2025, to regain compliance with the minimum bid price requirement.
On August 22, 2025, we received a second deficiency notice from the Nasdaq Staff notifying us that we were not in compliance with the minimum $10.0 million stockholders' equity requirement for continued listing on the Nasdaq Global Select Market. This second deficiency notice was only a notification of deficiency, not of imminent delisting, and had no immediate effect on the listing or trading of our securities on the Nasdaq Global Select Market.
On October 2, 2025, we received a letter from the Nasdaq Staff approving our application to list our securities on the Nasdaq Capital Market. Our securities were transferred to the Nasdaq Capital Market at the opening of business on October 6, 2025. In connection with the transfer to the Nasdaq Capital Market, Nasdaq granted us an additional 180 calendar day period, or until March 30, 2026, to regain compliance with the minimum bid price requirement. If, at any time before March 30, 2026, the closing bid price for our common stock is at least $1.00 per share for a minimum of 10 consecutive business days, the Nasdaq Staff will provide written notification to us that we are in compliance with the minimum bid price requirement, unless the Nasdaq Staff exercises its discretion to extend this 10-day period pursuant to the Nasdaq Listing Rules.
On February 23, 2026, our stockholders voted to adopt and approve an amendment to our restated certificate of incorporation, as amended, to effect a reverse stock split of our issued shares of common stock and our board of directors elected to implement a reverse stock split at a ratio of 1-for-14, which reverse stock split became effective on March 13, 2026 at 5:00 p.m. Eastern Time. However, if we do not regain compliance with the minimum bid price requirement by March 30, 2026, or if we do not meet the other listing standards, the Nasdaq Staff will provide us with notice that our common stock may be delisted. At that time, we may appeal the Nasdaq Staff’s delisting determination to a Nasdaq Listing Qualifications Panel. However, there can be no assurance that, even if we appeal the Nasdaq Staff’s delisting determination to the panel, such appeal would be successful.
We are required to comply with the continued listing requirements of the Nasdaq Stock Market LLC, or Nasdaq, including, among other things, maintaining a minimum closing bid price of $1.00 per share, referred to as the minimum bid price requirement, or shares of our common stock may be subject to delisting, which would have a material adverse effect on our business. In September 2024, we received a deficiency letter from the Listing Qualifications Department, or the Nasdaq Staff, informing us that we were not in compliance with the continued listing requirements of the Nasdaq Global Select Market because the bid price for our common stock had closed below $1.00 per share for 30 consecutive business days. In January 2025, we received written notification from the Nasdaq Staff informing us that we had regained compliance with the minimum bid price requirement as a result of our common stock maintaining a closing bid price of $1.00 per share or greater for at for at least 10 consecutive business days. However, there can be no assurance that we will be able to continue to maintain compliance with the minimum bid price requirement or any of the other Nasdaq continued listing requirements.
AnyIf potentialwe delistingare unable to comply with applicable Nasdaq listing standards, shares of our common stock would be subject to delisting, which could have a material adverse effect on the market for, and liquidity and price of, our common stock and would adversely affect our ability to raise capital on terms acceptable to us, or at all. Delisting from Nasdaq could also have other negative results, including, without limitation, the potential loss of confidence by investors, customers and employees and fewer business development opportunities. Any delisting of our common stock from Nasdaq would also make it more difficult for our stockholders to sell their shares of our common stock in the public market.
The recently implemented reverse stock split of our common stock may not achieve the intended benefits and could have a materially adverse effect on the market price of our common stock.
As discussed above, we recently implemented a reverse stock split of our common stock. The reverse stock split may not achieve the intended benefit of increasing the per share market price of our common stock, and there are a number of risks associated with the reverse stock split, including, without limitation:
the reverse stock split may not result in a price per share that will successfully attract certain types of investors, and such resulting share price may not satisfy the investing guidelines of institutional investors or investment funds;
the trading liquidity of the shares of our common stock may not improve, or may decline, as a result of the reverse stock split and there can be no assurance that the reverse stock split will result in the intended benefits; and the reverse stock split could be viewed negatively by the market and other factors, which may adversely affect the market price of our common stock.
There can also be no assurances the reverse stock split will prevent the delisting of our common stock from the Nasdaq Capital Market, which could have a material adverse effect on our business.
Since inception, we have incurred significant operating losses, including net losses of $35.0 and $58.2 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $418.8 million. We expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, masked immuno-oncology, or I-O, molecules through preclinical and clinical development, maintain the infrastructure necessary to support these activities and continue to incur costs associated with operating as a public company. We do not expect to generate any revenue from the sale of products for a number of years, if at all, and any such revenue will not be realized unless and until we obtain marketing approval for and successfully launch and commercialize a product candidate. If we obtain marketing approval for any current or future product candidates that we develop, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. Some of these expenses may be incurred in advance of marketing approval and could be substantial.
To date, we have financed our operations primarily from proceeds raised through private placements of equity securities; sales of common stock in our initial public offering, or IPO, and through “at-the-market” offerings; the sale of prefunded warrants in our June 2025 and February 2026 follow-on offerings; the exercise of certain common stock warrants issued in connection with our June 2025 follow-on offering; development event payments under our co-funded clinical trial collaboration with F. Hoffmann-La Roche Ltd, or Roche; and upfront and milestone payments under our collaboration and license agreements with AbbVie and Gilead. All of our programs are in clinical or preclinical development. As a result, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for at least the next several years, if at all.
We expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, masked I-O molecules through development. Our operating expenses and net losses may fluctuate significantly from quarter to quarter and year to year, and we expect to continue to incur significant expenses and operating losses for the foreseeable future, particularly to the extent we:
continue to advance our current research programs and conduct additional research programs;
advance our current product candidates and any future product candidates we may develop into preclinical and clinical development;
seek marketing approvals for product candidates that successfully complete clinical trials, if any;
obtain, expand, maintain, defend and enforce our intellectual property;
continue to discover, validate and develop additional product candidates;
continue to manufacture increasing quantities of our current or future product candidates for use in preclinical studies, clinical trials and for any potential commercialization;
acquire or in-license other product candidates, technologies or intellectual property;
hire additional personnel to support current or future programs;
establish a commercial and distribution infrastructure to commercialize products for which we may obtain marketing approval, if any; and incur additional costs associated with current and future research, development and commercialization efforts and operations as a public company.
Even if we successfully complete clinical trials and obtain regulatory approval for one or more of our product candidates, our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful commercialization of those product candidates. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve profitability. In addition, even if we are able to generate revenue from product sales, we may not become profitable.
Raising additional capital in the future may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to product candidates or our technology. In addition, the issuance of shares of common stock upon the exercise of our outstanding prefunded warrants or common stock warrants will result in immediate and substantial dilution to our existing stockholders.
Unless and until we can generate a substantial amount of product revenue, we expect to seek additional capital through a combination of public or private equity offerings, debt, collaborations, licensing arrangements or other sources. Our issuance of additional securities, whether equity or debt, or the possibility of such issuance, may cause the market price of our common stock to decline, and our stockholders may not agree with our plans for additional capital or the terms of such capital. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. In addition, the issuance of shares of common stock upon the exercise of our outstanding prefunded warrants or common stock warrants will result in immediate and substantial dilution to our existing stockholders. Similarly, if we issue additional shares of our common stock in one or more public or private offerings in the future, our existing stockholders will suffer further dilution. In addition, as a condition to providing additional funds to us, Gilead and AbbVie received rights superior to those of existing stockholders, and in connection with the issuance of prefunded warrants and common stock warrants in June 2025, we agreed to specified restrictions on our future equity issuances, unless we obtain the requisite prior approval of the warrant holders. Future investors may similarly receive rights that are superior to those of existing investors or which place restrictions on our future equity issuances. In addition, the incurrence of any indebtedness would result in additional payment obligations and is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, would be repaid before holders of our equity securities received any distribution of our corporate assets. Further, in raising funds through our collaborations and licensing arrangements with third parties, we have had to, and may in the future need to, relinquish valuable rights, partially or fully, to our technologies, future revenue streams, research programs or product candidates and grant licenses on terms unfavorable to us. In addition, securing additional capital would require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.
We have incurred significant operating losses since our inception and have not yet generated any revenue from the sale of products. If our product candidates are not successfully developed and approved, we may never generate any revenue from product sales. Our net losses were $58.2 million and $76.4 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $383.8 million. To date, we have financed our operations primarily from proceeds raised through private placements of preferred units and convertible preferred stock, a debt financing, our initial public offering, or IPO, of common stock in October 2021, private placements of our common stock and prefunded warrants, upfront payments under our license agreement with Gilead and collaboration agreement with AbbVie and our ATM offering program. We have devoted substantially all of our financial resources and efforts to research and development. We are still in the early stages of development of our tumor-activated, or masked, product candidates, and we have not completed clinical development for our clinical-stage product candidates, vilastobart (anti-CTLA-4) and XTX301 (IL-12). We expect to continue to incur significant expenses and operating losses for the foreseeable future, particularly to the extent we:
Even if we successfully complete clinical trials and obtain regulatory approval for one or more of our product candidates, our product candidates may not be commercially successful. In addition, we will continue to incur substantial research and development and other expenditures to develop and market additional product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We may not achieve profitability soon after generating product sales, if ever. If we are unable to generate revenue, we will not become profitable and may be unable to continue operations without continued funding.
successfully complete our ongoing and planned preclinical studies and clinical trials for any current or future product candidates;
successfully receive U.S. Food and Drug Administration, or FDA, clearance for any investigational new drug application, or IND, for any current or future product candidates;
successfully initiate and complete clinical trials for our clinical-stage product candidates and any other current or future product candidates, including all safety and efficacy studies necessary to obtain U.S. and foreign regulatory approval for our product candidates;
establish and maintain clinical and commercial manufacturing capabilities or make arrangements with third-party manufacturers for clinical supply and commercial manufacturing;
launch commercial sales of our products, if and when approved, whether alone or in collaboration with others;
obtain and maintain acceptance of the products, if and when approved, by patients, the medical community and third-party payors;
effectively compete with other therapies;
obtain and maintain healthcare coverage and adequate reimbursement for our products, if and when approved;
Management's Discussion & Analysis (MD&A)
New heading “Change in Fair Value of Common Stock Warrant Liabilities”
New heading “Other Income, Net”
New heading “Change in Fair Value of Common Stock Warrant Liabilities”
New heading “Valuation of Common Stock Warrant Liabilities”
Removed heading “Collaboration, License and Option Agreement with AbbVie Group Holdings Limited”
Removed heading “Stock Purchase Agreement and Investor Rights Agreement with AbbVie Inc.”
Removed heading “Loan and Security Agreement”
Removed heading “Recent Accounting Pronouncements”
Largest changes
“As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of December 31, 2024, we had cash and cash equivalents of $55.3 million. Based on our current operating plans, we anticipate that our cash and cash equivalents as of December 31, 2024, together with the $52.0 million in upfront payments received in the first quarter of 2025 in connection with our collaboration agreement with AbbVie, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026. …”see in full comparison
“As of December 31, 2024, we had cash and cash equivalents of $55.3 million. Based on our current operating plans, we anticipate that our cash and cash equivalents as of December 31, 2024, together with the $52.0 million in upfront payments received in the first quarter of 2025 in connection with our collaboration agreement with AbbVie, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026. …”see in full comparison
“Collaboration, License and Option Agreement with AbbVie Group Holdings Limited”see in full comparison
“our ability to obtain and maintain patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates if and when approved; and general economic conditions, including inflation and the imposition of new or revised global trade tariffs.”see in full comparison
“general economic conditions, including inflation and the imposition of new or revised global trade tariffs; and the costs of maintaining our operations and continuing to operate as a public company.”see in full comparison
“Stock Purchase Agreement and Investor Rights Agreement with AbbVie Inc.”see in full comparison
Full comparison: every changed paragraph (137)
The following discussion and analysis is meant to provide material information relevant to an assessment of the financial condition and results of operations of our company, including an evaluation of the amounts and uncertainties of cash flows from operations and from outside resources, so as to allow investors to better view our company from management’s perspective. You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K.10-K for the year ended December 31, 2025.
We are a clinical-stage biotechnology company discovering and developing masked immuno-oncology, or I-O, therapies with the goal of significantly improving outcomes for people living with cancer. Leveraging our clinically-validated masking technology and capabilities, we are developing I-O therapies designed to selectively activate within the tumor microenvironment to achieve durable efficacy without the severe side effects associated with systemically active I-O agents. Our integrated biology and protein engineering approach enables us to design and develop highly potent, masked biologics that are activated, or unmasked, by tumor-specific proteases within the tumor microenvironment. We are currently advancing multiple programs in preclinical and clinical development, including masked multi-specifics, and our clinically-validated masking technology has enabled us to establish top-tier strategic partnerships, including with AbbVie Group Holdings Limited, or AbbVie, and Gilead Sciences, Inc., or Gilead.
We are a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology, or I-O, therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. We are leveraging our proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including masked antibodies, bispecifics, cytokines and immune cell engagers. Current I-O therapies have curative potential for patients with cancer. However, their potential is significantly curtailed by systemic toxicity that results from activity of the therapeutic molecule outside the tumor microenvironment. Our molecules are engineered to localize activity within the tumor microenvironment with minimal systemic effects, resulting in the potential to achieve enhanced anti-tumor activity and increasing the population of patients who may be eligible to receive our medicines. To date, we have presented data across our clinical-stage programs showing clinical validation for our tumor-activation platform. Our most advanced clinical-stage product candidates are vilastobart (XTX101), an Fc-enhanced, tumor-activated, anti-CTLA-4 monoclonal antibody, or mAb, and XTX301, a tumor-activated, engineered interleukin 12, or IL-12, therapy. In addition to our clinical-stage product candidates, we are leveraging our proprietary tumor-activation platform to advance multiple preclinical programs for a masked PD-1/IL-2 bispecific and masked T cell engager molecules.
Recent DevelopmentsEvents
On March 12, 2026, we filed a certificate of amendment to our restated certificate of incorporation to effect 1-for-14 reverse stock split of our issued and outstanding shares of common stock, without any change to par value, which became effective at 5:00 P.M. Eastern Time on March 13, 2026. Unless otherwise indicated, all share amounts and per share amounts of our common stock have been adjusted retroactively in this Annual Report on Form 10-K to give effect to the reverse stock split for all periods presented.
In February 2026, we received net proceeds of approximately $37.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, upon the closing of a follow-on offering of prefunded warrants. In connection with the offering, we issued prefunded warrants to purchase 5,341,404 shares of our common stock. Each prefunded warrant is exercisable for one share of our common stock. The purchase price of each warrant was $7.4886. Each prefunded warrant has an exercise price of $0.0014 per share and will be exercisable from the date of issuance until fully exercised, subject to a beneficial ownership limitation for each holder.
Collaboration, License and Option Agreement with AbbVie Group Holdings Limited
On February 10, 2025, our wholly owned subsidiary Xilio Development, Inc., or Xilio Development, entered into a collaboration, license and option agreement with AbbVie Group Holdings Limited, or AbbVie, for up to four programs leveraging our proprietary tumor-activation technology and platform, consisting of (i) an exclusive option for (a) an initial program to discover, develop and commercialize masked T cell engager molecules for an agreed upon initial target and backup target, which we refer to as the initial option program, and (b) subject to the terms of the agreement, up to two additional programs to discover, develop, and commercialize masked T cell engager molecules for an initial target and backup target determined at the time of program initiation, each of which we refer to as an additional option program and (ii) an exclusive license for a program to develop and commercialize a masked antibody-based immunotherapy, which we refer to as the collaboration program. We refer to the initial option program and the additional option programs, collectively, as the option programs.
Under the agreement, we granted AbbVie an option to obtain an exclusive global license to exploit products discovered and developed under the initial option program. During the three-year period following the effective date of the agreement, AbbVie has the right to initiate up to two additional option programs by (a) selecting an initial target and backup target for each such additional option program (excluding the target known as PSMA) and any other target for which we have completed specified activities prior to lead selection) and (b) paying us an additional program nomination fee for each additional option program. In addition, on an option program-by-option program basis, prior to the initiation of specified activities related to lead optimization and selection for the initial target for such option program, AbbVie has a one-time right to substitute the initial target with the backup target agreed upon by the parties at the time of option program initiation, subject to the payment by AbbVie of a one-time substitution fee with respect to such substituted target and the other terms of the agreement.
For the initial option program, AbbVie’s option right is exercisable beginning on the effective date of the agreement, and for each additional option program, AbbVie’s option right is exercisable following delivery of written notice of nomination of such additional option program. For each option program, prior to option exercise, we will be responsible for conducting preclinical discovery and development up to the completion of investigational new drug application enabling studies, subject to AbbVie paying us option extension fees upon completion of specified stages of preclinical discovery and development. Unless AbbVie elects to extend preclinical development through the next stage and pays the applicable option extension fee, AbbVie’s option right terminates within a specified time period following completion of each stage of preclinical development. Upon exercising its option for an option program, AbbVie will be responsible for any remaining preclinical development, if applicable, and all clinical development, regulatory and commercialization activities with respect to licensed products under the applicable option program.
In connection with the collaboration program, we granted AbbVie an exclusive global license to exploit products discovered and developed under the collaboration program. We are responsible for conducting all preclinical development through lead generation, and AbbVie is responsible for all further development and commercialization activities for any licensed products generated under the collaboration program.
Under the agreement, we received $52.0 million in total upfront payments, consisting of a cash payment of $42.0 million and an equity investment of $10.0 million in our common stock at a purchase price of $2.30 per share. In addition, we will be eligible to receive up to approximately $2.1 billion in additional contingent payments, consisting of (i) up to $305.0 million in aggregate program nomination fees, preclinical development option extension fees and option fees for the option programs and (ii) up to $1.8 billion in aggregate development, regulatory and sales-based milestones for all option programs and the collaboration program. In addition, we are eligible to receive tiered royalties ranging in the mid to high single digits on annual global net product sales.
Stock Purchase Agreement and Investor Rights Agreement with AbbVie Inc.
In connection with the execution of the agreement, on February 10, 2025, we entered into a stock purchase agreement with AbbVie Inc. pursuant to which we issued and sold 4,347,826 of our shares of common stock to AbbVie Inc. in a private placement at a purchase price of $2.30 per share for an aggregate purchase price of $10.0 million.
Liquidity and Going Concern Overview
To date, we have financed our operations primarily from proceeds raised through private placements of preferredequity unitssecurities; andsales convertibleof preferredcommon stock,stock a debt financing,in our initial public offering, or IPO, and through “at-the-market” offerings; the sale of prefunded warrants in our June 2025 and February 2026 follow-on offerings; the exercise of certain common stock warrants issued in Octoberconnection 2021, private placements ofwith our commonJune stock2025 andfollow-on prefundedoffering; warrants,development upfrontevent payments under our licenseco-funded agreementclinical trial collaboration with GileadF. Sciences,Hoffmann-La Inc.,Roche Ltd., or Gilead,Roche; and upfront and milestone payments under our collaboration agreementand license agreements with AbbVie and Gilead. All of our at-the-market,programs are in early clinical or ATM,preclinical offeringdevelopment. program.As Wea result, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for at least the next several years, if at all. All of our programs are in early clinical or preclinical development. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates, if approved. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve profitability. Even if we are able to generate revenue from product sales, we may not become profitable.
In June 2025, we closed a follow-on offering of prefunded warrants and accompanying common stock warrants and received net proceeds of $47.0 million. In connection with the offering, we issued prefunded warrants to purchase 4,762,533 shares of common stock, accompanied by Series A warrants to purchase 4,762,533 shares of common stock (or, in certain circumstances, prefunded warrants), Series B warrants to purchase 4,762,533 shares of common stock (or, in certain circumstances, prefunded warrants) and Series C warrants to purchase 4,762,533 shares of common stock (or, in certain circumstances, prefunded warrants). Through December 31, 2025, 3,443,388 of the Series B warrants were exercised for 1,008,415 shares of common stock and 2,434,973 prefunded warrants in lieu of shares of common stock. We received approximately $35.8 million in total gross proceeds from the exercise of the Series B warrants, before deducting underwriting discounts and commissions and any offering expenses. An aggregate of 3,443,388 Series C warrants, which are exercisable between June 1, 2026 and December 2, 2026, remain outstanding and 1,319,145 Series C warrants expired on December 31, 2025 according to their terms in connection with the expiration of unexercised Series B warrants. If all of the outstanding Series C warrants are exercised for cash at their current exercise price of $10.50 per warrant, we would receive up to $36.2 million in additional total gross proceeds in the second half of 2026, before deducting underwriting discounts and commissions and any offering expenses.
continue to advance our current research programs and conduct additional research programs;
advance our current product candidates and any future product candidates we may develop into preclinical and clinical development;
seek marketing approvals for product candidates that successfully complete clinical trials, if any;
obtain, expand, maintain, defend and enforce our intellectual property;
continue to discover, validate and develop additional product candidates;
continue to manufacture increasing quantities of our current or future product candidates for use in preclinical studies, clinical trials and for any potential commercialization;
acquire or in-license other product candidates, technologies or intellectual property;
hire additional personnel to support current or future programs;
establish a commercial and distribution infrastructure to commercialize products for which we may obtain marketing approval, if any; and incur additional costs associated with current and future research, development and commercialization efforts and operations as a public company.
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of December 31, 2025, we had cash and cash equivalents of $137.5 million. In the first quarter of 2026, we received net proceeds of approximately $37.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, upon the closing of a follow-on offering of prefunded warrants and a $5.0 million development milestone related to the collaboration agreement with AbbVie. Based on our current operating plans, we anticipate that our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the end of 2027. This estimate excludes any potential future milestone payments, option-related fees or other contingent payments under our existing collaboration and partnership agreements with AbbVie and Gilead and excludes the potential receipt of up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.
In addition, we have based our estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we anticipate. We expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, masked I-O molecules through preclinical and clinical development, maintain the infrastructure necessary to support these activities and continue to incur costs associated with operating as a public company.
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of December 31, 2024, we had cash and cash equivalents of $55.3 million. Based on our current operating plans, we anticipate that our cash and cash equivalents as of December 31, 2024, together with the $52.0 million in upfront payments received in the first quarter of 2025 in connection with our collaboration agreement with AbbVie, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026. Since these amounts are not expected to be sufficient to fund our operations for at least twelve months from the date of issuance of the consolidated financial statements included elsewhere in this Annual Report on Form 10-K, there is substantial doubt about our ability to continue as a going concern. Our management has developed plans to fund our operations, which primarily consist of raising additional capital through one or more of the following: additional equity or debt financings; additional collaborations, partnerships or licensing transactions; or other sources. However, there can be no assurance that we will be able to complete any such transaction on acceptable terms or otherwise, and we may be unable to obtain sufficient additional capital. If we are not able to secure sufficient additional capital in the near term, we will need to implement additional cost reduction strategies, which could include delaying, limiting, further reducing or eliminating both internal and external costs related to our operations and research and development programs. For more information, refer to “—Liquidity and Capital Resources—Capital Requirements and Going Concern” below and Note 1 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Revenue
We have not generated any revenue from the sale of products since inception and do not expect to generate any revenue from the sale of products for at least the next several years, if at all. If our development efforts for our current or future product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales. For the foreseeable future, we expect substantially all of our revenue, if any, would be generated from our collaboration and license agreements with GileadAbbVie and AbbVie.Gilead. For more information on our collaborationcollaboration, license and licenseoption agreementsagreement with GileadAbbVie and AbbVie,our license agreement with Gilead, please see Note 6, Collaboration and License Agreements, and Note 14, Subsequent Events, respectively,6 to our consolidated financial statements appearingincluded elsewhere in this Annual Report on Form 10-K.
personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation expense for employees engaged in research and development functions;
costs incurred with third-party contract development and manufacturing organizations, or CDMOs, to acquire, develop and manufacture materials for both preclinical studies and current or future clinical trials;
costs of funding research performed by third parties that conduct research and development and preclinical activities on our behalf;
costs incurred with third-party contract research organizations, or CROs, and other third parties in connection with the conduct of our current or future clinical trials;
costs of sponsored research agreements and outside consultants, including their fees and related expenses;
costs incurred to maintain compliance with regulatory requirements;
fees for maintaining licenses and other amounts due under our third-party licensing agreements;
expenses incurred for the procurement of materials, laboratory supplies and non-capital equipment used in the research and development process; and depreciation, amortization and other direct and allocated expenses, including rent, maintenance of facilities and other operating costs, incurred as a result of our research and development activities.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will remain approximately the same or will continue to increase for the foreseeable future as we advance our programs and our current or future product candidates into and through the development phase. We expect our discovery research efforts and our related personnel costs to remain consistent with historical levels. In addition, as we progress our most advanced product candidates in clinical development, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we have entered into, or may enter into license, acquisition, option or other agreements to acquire the rights to future products and product candidates. In the event we are unable to raise sufficient additional capital in the near term to fund our operations,operations in the future, we willmay be requiredneed to adoptimplement cost reduction strategies that seek to maintain our ability to continue the development of our most advanced product candidates in clinical development while otherwise reducing our overall research and development expenses.
At this time, we cannot reasonably estimate or know the nature, timing and projected costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates or programs. This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:
the scope, timing, costs and progress of preclinical and clinical development activities;
the number and scope of preclinical and clinical programs we decide to pursue;
our ability to implement and maintain cost reduction strategies, as well as the timing of such cost reductions;
our ability to maintain our current research and development programs;
our ability to establish an appropriate safety profile for our product candidates with IND-enabling studies;
our ability to hire and retain key research and development personnel;
the costs associated with the development of any additional product candidates we acquire or develop through collaborations, partnerships, licenses or similar transactions;
our successful enrollment in and completion of clinical trials;
our ability to successfully complete clinical trials with safety, potency and purity profiles that are satisfactory to the U.S. Food and Drug Administration, or the FDA, or any comparable foreign regulatory authority;
our receipt of regulatory approvals from applicable regulatory authorities;
our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize, our product candidates;
our ability to commercialize products, if and when approved, whether alone or in collaboration with others;
the continued acceptable safety profiles of the product candidates following approval, if any;
our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates are approved;
the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder, if any;
our ability to obtain and maintain patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates if and when approved; and general economic conditions, including inflation and the imposition of new or revised global trade tariffs.
General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits, recruiting and stock-based compensation, for personnel in our executive, finance, legal, business development, human resources and other administrative functions. General and administrative expenses also include legal fees relating to corporate matters; professional and consulting fees for accounting, auditing, tax, human resources and administrative consulting services; board of directors’ fees; insurance costs; and facility-related expenses, which include depreciation costs and other allocated expenses for rent, maintenance of facilities,facilities and other general administrative costs. These costs relate to the operation of the business and are in support of but separate from the research and development function and our individual development programs. Costs to secure and defend our intellectual property are expensed as incurred and are classified as general and administrative expenses.
We anticipate that our general and administrative expenses will remain consistent with historical levels as we maintain our infrastructure to support our research and development activities. We also expect to continue to incur significant expenses associated with operating as a public company, including increased costs for accounting, audit, legal, regulatory and tax-related services attributable to maintaining compliance with exchange listing standards and U.S. Securities and Exchange Commission, or SEC, requirements, directors’ and officers’ liability insurance costs and investor and public relations costs. We also expect to continue to incur additional expenses related to intellectual property as we file patent applications to protect intellectual property arising from our research and development activities. In the event we are unable to obtain sufficient additional capital in the near term,future, we willmay need to implement cost reduction strategies that seek to reduce our general and administrative expenses while maintaining sufficient infrastructure to support our planned research and development activities and operations as a public company.
In connection with oura March 2024 strategic portfolio reprioritization and restructuring in March 2024,restructuring, we undertook efforts to reduce our expenses and streamline our operations, including a reduction in headcount of 15 employees, representing approximately 21% of our workforce immediately prior to the workforce reduction. Restructuring expense consists of costs directly incurred as a result of restructuring initiatives, and includes employee severance payments, benefits continuation, outplacement services and related expenses.
What changed in the latest 10-Q
Risk Factors
Largest changes
“We also face additional emerging risks associated with the use of generative AI and related technologies, which we have implemented, and may further expand, into our operations. The development and use of AI, combined with an uncertain regulatory environment, introduce risks and challenges that may result in reputational harm, liability, or other adverse consequences to our business operations. In addition, we may face competitive risks if we fail to adopt AI or other machine learning technologies in a timely fashion. …”see in full comparison
“In addition, the U.S. Trade Representative is currently conducting two investigations under Section 301 of the Trade Act, which may also result in additional tariffs. In June 2026, in one such investigation, it proposed additional tariffs of 10% to 12.5% on products of 60 economies determined to have failed to impose and effectively enforce a prohibition on the importation of goods produced with forced labor. …”see in full comparison
In 2025, the U.S. government initiated a series of tariff-related actions against U.S. trading partners, which included a number of reciprocal and country-specific tariffs under the International Emergency Economic Powers Act, or the IEEPA. In February 2026, the U.S. Supreme Court held that the IEEPA does not authorize the President to impose tariffs, invalidating both the “reciprocal” tariffs and certain country-specific tariffs. The President subsequently invoked Section 122 of the Trade Act ofsee in full comparison19741974, or the Trade Act, to impose a 10% tariff, which could be raised to 15%, on nearly all foreign imports. The tariffs imposed under Section 122 are temporary and valid for 150 days without congressional approval.MultipleOnstatesMayhave7,challenged2026, the U.S. Court of International Trade ruled that these tariffsinwerecourt.Theunlawful and issued a permanent injunction for certain named private party plaintiffs and the State of Washington. The U.S.TradegovernmentRepresentativeappealedconcurrentlytoinitiatedthetwoU.S.investigationsCourtunderofSectionAppeals301for the Federal Circuit and, on June 11, 2026, the Federal Circuit stayed enforcement of theTradelowerActcourt’sofpermanent1974,injunctionwhichpendingmayfurtheralso result in additional tariffs.appeals.
Further, the FDA may determine that we must provide additional evidence and data before approving a BLA for our product candidates. For example, the FDA reviews an application to determine whether there is “substantial evidence” to support a finding of effectiveness for the proposed product for its intended use(s).see in full comparisonTheIn most cases, the default requirement for FDAhasapprovalinterpretedofthisaevidentiarynewstandardproducttoisgenerally require at least twoone adequate and well-controlledclinical trials to establish effectiveness of a new product. Under certain circumstances, however, the FDA has indicated that a single trial with certain characteristics and additional confirmatory evidence may satisfy this standard. The FDA issued draft guidance in September 2023 that outlines considerations for relying on confirmatory evidence in lieu of a secondpivotal clinical trialtoplusdemonstrateconfirmatoryeffectiveness.evidence.InHowever, in the event that we submit a BLA on the basis of one clinical trial and confirmatory evidence, the FDA could determine that such information is not sufficient to support approval of theapplicationapplication, and theagencyFDA could require us to conduct an additional trial in support of the BLA.
We have relied on WuXi Biologics in China to manufacture and supply certain raw materials used in our product candidates, and we expect to continue to use WuXi Biologics as our CDMO for such purposes. A natural disaster, epidemic or pandemic, such as the COVID‑19 pandemic, trade war, political unrest, economic conditions, changes in legislation, including the passage of the People’s Republic of China Biosecurity law, which became effective on April 15, 2021, and subsequent legislation that China or the U.S. may adopt in the future, or other events in China could disrupt our ability to continue to rely upon CROs, CDMOs, collaborators, manufacturers or other third parties with whom we conduct business now or in the future. For example, in December 2025, the BIOSECURE Act was signed into law as part of the Fiscal Year 2026 National Defense Authorization Act. Under the BIOSECURE Act, U.S. government agencies cannot (i) buy or obtain biotechnology equipment or services provided by biotechnology companies of concern, or BCCs; (ii) enter into, extend, or renew a contract with any entity using biotechnology equipment or services provided by a BCC to perform a government contract; or (iii) expend loan or grant funds for biotechnology equipment or services provided by a BCC, whether directly or through a loan or grant recipient. The BIOSECURE Act does not name specific companies as BCCs but treats any company on the Department of Defense/War 1260H list of “Chinese military companies” as a BCC. The 1260H list was updated by the Department of Defense in January 2024 and January 2025.see in full comparisonInSubsequently,Februaryon June 8, 2026, the Department of Defense/Warpublishedreleased an updated version of the 1260H list, which included WuXi AppTec,butalongthenwithabruptlytwowithdrewother biotechnology companies (Complete Genomics and Novogene). WuXi AppTec has challenged its designation as a Chinese military company and litigation remains ongoing. Since WuXi AppTec was just added to thelist.list,Theitimplicationswill be covered under a five-year grandfather clause that allows any contracts signed before the effective date ofthistheactionbanremaintounclear.be protected through 2031. Moreover, while WuXi Biologics was originally the biologics division of WuXi AppTec, they are now operationally independent companies. As a result, we do not expect the recent 1260H listing of WuXi AppTec to impact WuXi Biologics and the services it currently provides to us. Nonetheless, the U.S. government has authority to add additional entities of concern to the 1260H list, and there is a risk that such a future listing could include WuXi Biologics.
We depend on our information technology systems and those of our third-party service providers, and any failure of these systems could harm our business. Security breaches, loss of data, inability to access systems, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability or competitive or reputational harm, which could adversely affect our business, results of operations and financial condition. In addition, artificial intelligence, or AI, presents emerging risks and challenges that may impact our business.see in full comparison
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As of MarchJune 31,30, 2026, we had cash and cash equivalents of $150.3$136.0 million. In the second quarter of 2026, we achieved a $6.0 million development milestone relatedunder toour AbbVie collaboration, which we received in the collaborationthird agreementquarter withof AbbVie Group Holdings Limited, or AbbVie.2026. Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of MarchJune 31,30, 2026, together with the $6.0 million development milestone achieved under theour AbbVie collaboration in the second quarter of 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into earlythe first quarter of 2028. This estimate excludes any potential additional milestone payments, option-related fees or other contingent payments under our existing collaboration and partnership agreements with AbbVie and Gilead Sciences, Inc., or Gilead, and excludes the potential receipt of up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.price and any potential additional milestone payments, option-related fees or other contingent payments under our collaboration and license agreements with AbbVie Group Holdings Limited, or AbbVie, and Gilead Sciences, Inc., or Gilead, including up to $31.0 million in near-term milestones and option extension fees that could be achieved under the AbbVie collaboration through the first half of 2027. In addition, we have based our estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we anticipate and may need to seek additional capital sooner than anticipated.
the scope, progress, results and costs of research and development for our current and future product candidates, including our current and planned clinical trials for our clinical-stage product candidates, vilastobartefarindodekin alfa and efarindodekin alfa,XTX501, and ongoing preclinical development for our current and future product candidates;
Since inception, we have incurred significant operating losses, including net losses of $9.5$15.9 million and $13.3$29.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectivelyrespectively, and $35.0 million for the year ended December 31, 2025. As of MarchJune 31,30, 2026, we had an accumulated deficit of $428.3$434.7 million. We expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, masked immuno-oncology, or I-O, molecules through preclinical and clinical development, maintain the infrastructure necessary to support these activities and continue to incur costs associated with operating as a public company. We do not expect to generate any revenue from the sale of products for a number of years, if at all, and any such revenue will not be realized unless and until we obtain marketing approval for and successfully launch and commercialize a product candidate. If we obtain marketing approval for any current or future product candidates that we develop, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. Some of these expenses may be incurred in advance of marketing approval and could be substantial.
Even if we generate taxable income in the future, our ability to use our NOL carryforwards and tax attributes may nevertheless be limited. In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in the ownership of its equity by certain stockholders over a three-year period), the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income is subject to limitations. We have experienced ownership changes as defined by Sections 382 and 383 of the Code. As a result of these changes and any future ownership changes, if we earn net taxable income, our ability to use our pre-change NOL carryforwards and other pre-change tax attributes to offset such taxable income may be subject to limitations, which could result in increased future tax liability to us and could have an adverse effect on our future results of operations.
Our business and future success is highly dependent on our ability to obtain regulatory approval for, and if approved, successfully launch and commercialize, our current or future product candidates, including our clinical-stage,current masked I-Oclinical-stage product candidates:candidates, vilastobartefarindodekin alfa and efarindodekin alfa.XTX501. We are currently evaluating vilastobart in combination with atezolizumab (Tecentriq®) in an ongoing Phase 2 clinical trial in patients with microsatellite stable, or MSS, metastatic colorectal cancer, or mCRC, and we are currently evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with certain advanced solid tumors. For XTX501, we expect to initiate dosing in the Phase 1 trial in patients with metastatic non-small cell lung cancer, or NSCLC, and select advanced solid tumors in the second half of 2026. We also have a portfolio of programs that are in earlier stages of development and may never advance to clinical-stage development, including XTX501, our bispecific PD-1/masked IL-2, which is designed to selectively stimulate PD-1 positive antigen-experienced T cells and enhance their function and is currently advancing in initial IND-enabling activities, and our wholly-owned preclinical programs for a multi-specific masked T cell engager targeting prostate-specific membrane antigen, or PSMA, and six-transmembrane epithelial antigen of prostate 1, or PSMA+STEAP1, and a masked T cell engager targeting claudin 18.2, or CLDN18.2,CLDN18.2 as well as an additional masked T cell engager program in collaboration with AbbVie.
To date, we have only had limited interactions with the FDA regarding our clinical development plans. We may experience issues surrounding preliminary trial execution, such as delays in FDA acceptance of any future INDs, revisions in trial design and finalization of trial protocols, difficulties with patient recruitment and enrollment, quality and provision of clinical supplies, or early safety signals.
All our product candidates are still in the early clinical stage or preclinical stage of development, and their risk of failure is high. Before we can commence clinical trials for a product candidate, we must complete extensive preclinical testing and studies that support our planned INDs in the U.S., or similar applications in other jurisdictions. We cannot be certain of the timely completion or outcome of our preclinical testing and studies, and we cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our current or future preclinical programs, including without limitation, the planned INDINDs for XTX501,our masked T cell engager programs targeting CLND18.2 and PSMA+STEAP1, on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.
The risk of failure for our current and any future product candidates is high. It is impossible to predict when or if any of our product candidates will successfully complete preclinical studies or clinical trials evaluating their safety and effectiveness in humans or will ultimately receive regulatory approval. To obtain the requisite regulatory approvals to market and sell any of our product candidates, we must demonstrate through extensive preclinical studies and clinical trials that our product candidates are safe and effective in humans for use in each target indication. Preclinical and clinical testing is expensive and can take many years to complete, and the outcome is inherently uncertain. Failure can occur at any time during the preclinical or clinical trial process. The outcome of preclinical testing and early clinical trials may not be predictive of the results of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. In particular, while we have conducted certain preclinical studies for each of our clinical stage product candidates, we do not know whether these product candidates will perform in our clinical trials as they have performed in these prior preclinical studies. Similarly, there can be no assurance that early, interim or preliminary clinical data or results will be predictive of or replicated in future clinical data or results, including without limitation, the data reported to date for our Phase 1/2 trial for vilastobart in combination with atezolizumab and our Phase 1clinical trial for efarindodekin alfa. Many companies in the biopharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events, or AEs. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products.
Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidate for its intended indications. We cannot guarantee that any clinical trials, including our ongoing Phase 2 clinical trial evaluating vilastobart in combination with atezolizumab or our Phase 2 clinical trial evaluating efarindodekin alfa as a monotherapy,monotherapy and our Phase 1/2 clinical trial to evaluate XTX501 in patients with NSCLC and select advanced solid tumors, will be conducted as planned or completed on schedule, if at all. We may experience numerous unforeseen events leading up to, during or as a result of clinical trials that could delay or prevent the initiation or completion of a clinical trial or our ability to receive marketing approval or commercialize our product candidates, including:
From time to time, we may publish interim top-line or preliminary data from our clinical trials. For example, we most recently reported updated data from our Phase 2 clinical trial for vilastobart in combination with atezolizumab and from our Phase 1 clinical trial for efarindodekin alfa in November 2025 at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting. Preliminary and interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.
We intend to develop our clinical-stage product candidates, and likely other future product candidates, in combination with third-party cancer drugs, which may be either approved or unapproved. For example, we are currently evaluating vilastobart in combination with atezolizumab (Tecentriq®) in a Phase 2 clinical trial in patients with MSS mCRC. Our ability to develop and ultimately commercialize our current product candidates, and any future product candidates, used in combination with third-party drugs will depend on our ability to access such drugs on commercially reasonable terms for clinical trials and their availability for use with our commercialized product, if approved. We cannot be certain that current or potential future commercial relationships will provide us with a steady supply of such drugs on commercially reasonable terms or at all. Any failure to maintain or enter into new successful commercial relationships, or the expense of purchasing such third-party drugs in the market, may delay our development timelines, increase our costs and jeopardize our ability to develop our current product candidates and any future product candidates as commercially viable therapies. If any of these occur, our business, financial condition, operating results or prospects may be materially harmed.
The success of our business depends primarily upon our ability to discover, develop and commercialize products based on our technological approaches. While we have had favorable preclinical and early clinical results related to certain of our clinical-stage product candidates, vilastobart and efarindodekin alfa, we have not yet succeeded and may not succeed in demonstrating efficacy and safety for any product candidates in current or future clinical trials or in obtaining marketing approval thereafter. We rely on matrix metalloproteases, or MMPs, and other tumor-specific proteases to activate our molecules within the tumor microenvironment. If MMPprotease activity in human tumors is not sufficient to cleave the masking protein domain, the potential efficacy of our product candidates would be limited. We have no assurance that our product candidates will successfully progress through clinical development and ultimately marketing approval. We have invested substantially all of our efforts and financial resources in developing our initial product candidates and our future success is highly dependent on the outcome of our ongoing clinical trials and the successful development of our technology and product candidates.
We have relied on WuXi Biologics in China to manufacture and supply certain raw materials used in our product candidates, and we expect to continue to use WuXi Biologics as our CDMO for such purposes. A natural disaster, epidemic or pandemic, such as the COVID‑19 pandemic, trade war, political unrest, economic conditions, changes in legislation, including the passage of the People’s Republic of China Biosecurity law, which became effective on April 15, 2021, and subsequent legislation that China or the U.S. may adopt in the future, or other events in China could disrupt our ability to continue to rely upon CROs, CDMOs, collaborators, manufacturers or other third parties with whom we conduct business now or in the future. For example, in December 2025, the BIOSECURE Act was signed into law as part of the Fiscal Year 2026 National Defense Authorization Act. Under the BIOSECURE Act, U.S. government agencies cannot (i) buy or obtain biotechnology equipment or services provided by biotechnology companies of concern, or BCCs; (ii) enter into, extend, or renew a contract with any entity using biotechnology equipment or services provided by a BCC to perform a government contract; or (iii) expend loan or grant funds for biotechnology equipment or services provided by a BCC, whether directly or through a loan or grant recipient. The BIOSECURE Act does not name specific companies as BCCs but treats any company on the Department of Defense/War 1260H list of “Chinese military companies” as a BCC. The 1260H list was updated by the Department of Defense in January 2024 and January 2025. InSubsequently, Februaryon June 8, 2026, the Department of Defense/War publishedreleased an updated version of the 1260H list, which included WuXi AppTec, butalong thenwith abruptlytwo withdrewother biotechnology companies (Complete Genomics and Novogene). WuXi AppTec has challenged its designation as a Chinese military company and litigation remains ongoing. Since WuXi AppTec was just added to the list.list, Theit implicationswill be covered under a five-year grandfather clause that allows any contracts signed before the effective date of thisthe actionban remainto unclear.be protected through 2031. Moreover, while WuXi Biologics was originally the biologics division of WuXi AppTec, they are now operationally independent companies. As a result, we do not expect the recent 1260H listing of WuXi AppTec to impact WuXi Biologics and the services it currently provides to us. Nonetheless, the U.S. government has authority to add additional entities of concern to the 1260H list, and there is a risk that such a future listing could include WuXi Biologics.
Separately from our reliance on WuXi Biologics for manufacturing, we engage WuXi AppTec to perform a significant portion of the nonclinical and IND-enabling studies for our product candidates. However, because we do not use WuXi AppTec’s services in the performance of any U.S. government contract, and do not rely on U.S. government grant or loan funds for such services, we do not expect the listing of WuXi AppTec to have a material impact on our operations, and we believe we could transition these services to alternative providers in a timely manner, if necessary. Nonetheless, if we were to seek or rely on U.S. government contracts, grants, or loans in the future, or if the U.S. government were to expand the restrictions applicable to entities on the 1260H list (including through WuXi AppTec’s potential designation under other U.S. restricted party regimes) and we were unable to transition these services on a timely and cost-effective basis, such developments could adversely affect our business.
Any disruption in China or the U.S. that significantly impacts WuXi BiologicsBiologics, WuXi AppTec or other third parties with whom we conduct business now or in the future, including CROs that provide services for our research and development programs, or manufacturers that produce and export raw or manufactured materials in adequate quantities to meet our needs, could impair our ability to operate our business on a day-to-day basis and impede, delay, limit or prevent the research, development or commercialization of our current and future products or product candidates. In addition, for any activities conducted in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the U.S. or Chinese governments, political unrest or unstable economic or geopolitical conditions, including sanctions in China or against certain Chinese companies; changes in U.S. export laws or the imposition by the U.S. of trade barriers; sanctions; limitations on uses of U.S. government executive agency contract, grant or loan funds; or other restrictions on doing business with certain Chinese companies, including WuXi Biologics, which could have a material adverse effect on our business. Additionally, we may be exposed to fluctuations in the value of the local currency in China for goods and services. Our costs for any of these services or activities could also increase as a result of future appreciation of the local currency in China or increased labor costs if the demand for skilled laborers increases and/or the availability of skilled labor declines in China.
We rely, and expect to relycontinue to rely, on third parties, including but not limited to, CROs and research and clinical trial sites to ensure our IND-enabling studies and clinical trials are conducted properly and on time, and we expect to rely in the future on third-party vendors for additional research programs as well as other functions. While we will have agreements governing their activities, we will have limited influence over their actual performance. We will control only certain aspects of our third-party vendors’ activities. Nevertheless, we will be responsible for ensuring that each of these studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the third-party vendors does not relieve us of our regulatory responsibilities.
If our current or future collaborations, licenses or similar transactions do not result in the successful development and commercialization of product candidates, including if one of our current or future collaborators or licensors terminates its agreement with us, we may not receive any future payments for which we might otherwise be eligible under such agreement or we may incur significant costs in re-establishing the development and manufacturing of such product candidates. If we do not receive the funding we expect under these agreements, our development of product candidates could be delayed, and we may need additional resources to develop such product candidates. In addition, if one of our collaborators terminates its agreement with us, we may find it more difficult to find a suitable replacement collaborator or licensor or for us to attract new collaborators or licensors, and our development programs may be delayed or the perception of us in the business and financial communities could be adversely affected. All of the risks relating to product development, regulatory approval and commercialization described in this Annual“Risk ReportFactors” on Form 10-Ksection apply to the activities of our collaborators or licensors.
We are developing our most advanced clinical-stage, masked I-Oclinical-stage product candidates for the treatment of cancer and have not completed clinical development or received marketing approval for eitherany vilastobartof orour efarindodekinproduct alfa.candidates. There are already a variety of available therapies marketed for cancer and some of the currently approved therapies are branded and subject to patent protection, and others are available on a generic basis. Many of these approved therapies are well-established and widely accepted by physicians, patients and third-party payors. Insurers and other third-party payors may also encourage the use of generic products. We expect that if our product candidates are approved, they will be priced at a significant premium over competitive generic products. This may make it difficult for us to achieve our business strategy of using our product candidates in combination with existing therapies or replacing existing therapies with our product candidates. Competition may further increase with advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.
With respect to our masked T cell engager programs, currently there are no T cell engager therapies targeting PSMA, CLDN18.2 or STEAP1 approved for the treatment of cancer. However, we are aware of other companies that have masked T cell engager programs in development for PSMA, including but not limited to Janux Therapeutics, Inc. and Vir Biotechnology, Inc., and at least one other company, Werewolf Therapeutics, Inc., that has a masked T cell engager program in development for STEAP1. To our knowledge, there are no companies currently developing a masked T cell engager program targeting both PSMA and STEAP1 or a masked T cell engager program for CLDN18.2. However, we are aware of several companies developing non-masked T cell engager programs for CLDN18.2, including but not limited to AmgenAstraZeneca Inc.,PLC, Lunan Pharmaceutical Group Co. Ltd., Qilu Pharmaceutical Co. and Xencor, Inc. (licensed to Astellas Pharma Inc., AstraZeneca PLC, GSK plc, Lunan Pharmacuetical Group Co. Ltd. and Qilu Pharmaceutical Co.,Inc.), for PSMA, including but not limited to GSK plc, Regeneron PharmaceuticalsPharmaceuticals, Inc. and Xencor, Inc. (licensed to Johnson & Johnson), and for STEAP1, including but not limited to XencorXencor, Inc. (licensed to Amgen Inc.) and Shanghai Henlius Biotech, Inc.
With respect to efarindodekin alfa, currently there are no IL-12 therapies approved for the treatment of cancer. However, we are aware of several companies that have systemically delivered IL-12 delivery programs in development, including but not limited to PDS Biotechnology Corporation, Philogen S.p.A., Shanghai KangaBio Co., Ltd. and Werewolf Therapeutics, Inc.
As is the case with other biotechnology companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the U.S. continues to adapt to wide-ranging patent reform legislation that became effective starting in 2012. Moreover, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty regarding our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on new legislation and decisions by the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. For example, the U.S. Supreme Court, in the case Amgen v. Sanofi, held that broad functional antibody claims are invalid for lack of enablement. In addition, in Juno v. Kite, the U.S. Court of Appeals for the Federal Circuit held claims reciting broad antibody genus based on function invalid for lack of written description. Recently,In 2023 and 2024, respectively, the Federal Circuit issued precedential decisions in In re Cellect and Allergan v. MSN that could shorten or eliminate an extended patent term awarded under patent term adjustment in certain patent family members if challenged on the basis of obviousness-type double patenting. Recently, the Federal Circuit in Teva Pharmaceuticals v. Eli Lilly held that method-of-treatment claims reciting a genus of antibodies for a new therapeutic use satisfied the written description and enablement requirements if the claimed antibody genus was well-known in the art. Additionally, the U.S. Supreme Court in Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc. held that induced infringement of pharmaceutical method-of-use patents generally requires affirmative acts encouraging infringement, and that the mere marketing of a product with a “skinny label” is insufficient. While we do not believe that any of the patents owned or licensed by us will be found invalid based on these decisions, we cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents. Similarly, changes in the patent laws of other jurisdictions could adversely affect our ability to obtain and effectively enforce our patent rights, which would have a material adverse effect on our business and financial condition.
If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates. We are generally also subject to all of the same risks described in this Annual“Risk ReportFactors” on Form 10-Ksection with respect to protection of intellectual property that we license as we are for intellectual property that we own. If we or our licensors fail to adequately obtain or protect this intellectual property, our ability to commercialize products could suffer.
Recent or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. For example, the AIA implemented in March 2013, moved the U.S.
Recent or future patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. For example, the AIA implemented in March 2013, moved the U.S. from a “first to invent” to a “first-to-file” system. Under a “first-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to a patent on the invention regardless of whether another inventor had made the invention earlier. The AIA includes a number of other significant changes to U.S. patent law, including provisions that affect the way patent applications are prosecuted, redefine prior art and establish a USPTO-administered post-grant review system that has affected patent litigation. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.
Further, the FDA may determine that we must provide additional evidence and data before approving a BLA for our product candidates. For example, the FDA reviews an application to determine whether there is “substantial evidence” to support a finding of effectiveness for the proposed product for its intended use(s). TheIn most cases, the default requirement for FDA hasapproval interpretedof thisa evidentiarynew standardproduct tois generally require at least twoone adequate and well-controlled clinical trials to establish effectiveness of a new product. Under certain circumstances, however, the FDA has indicated that a single trial with certain characteristics and additional confirmatory evidence may satisfy this standard. The FDA issued draft guidance in September 2023 that outlines considerations for relying on confirmatory evidence in lieu of a secondpivotal clinical trial toplus demonstrateconfirmatory effectiveness.evidence. InHowever, in the event that we submit a BLA on the basis of one clinical trial and confirmatory evidence, the FDA could determine that such information is not sufficient to support approval of the applicationapplication, and the agencyFDA could require us to conduct an additional trial in support of the BLA.
The FDA and comparable regulatory agencies in foreign jurisdictions, such as the EMA and Committee for Medicinal Products for Human Use, play an important role in the development of our product candidates by providing guidance on our clinical development programs and reviewing our regulatory submissions, including INDs, requests for special designations and marketing applications. If these oversight and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of our product candidates could be impacted in a negative manner. For example, on July 14, 2025, following litigation reaching the U.S. Supreme Court, the current administration began to carry out layoffs across HHS, including at the FDA. The loss of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, review, and approval of our product candidates. In November 2025, Congress agreed to provide full-year funding for the FDA through September 30, 2026, at a slight decrease compared to previous spending levels. There were several reports in 2025 of the FDA failing to meet its Prescription Drug User Fee Act, or PDUFA, goal dates for approval of a new drug application, or NDA, or BLA due to heavy workload and limited resources.
In addition, while the FDA’s review of marketing applications and other activities for new drugs and biologics is largely funded through the user fee program established under the Prescription Drug User Fee Act, or PDUFA, it remains unclear how the current administration’s efforts to reduce the workforce of HHS and budget cuts will impact this program and the ability of the FDA to provide guidance and review our product candidates in a timely manner. For example, while the reduction in workforce reportedly did not specifically target FDA reviewers, many operations, administrative and policy staff that help support such reviews were affected, and those losses could lead to delays in PDUFA reviews and related activities. In addition, there is a risk that the reduction in workforce and budget cutbacks could threaten the integrity of the PDUFA program itself, because in order for the FDA to obligate user fees collected under PDUFA in the first place, a certain amount of non-user fee appropriations must be spent on the process for the review of applications plus certain other costs during the same fiscal year.
The FDA and Congress may further reevaluate the Orphan Drug Act and its regulations and policies. ThisFor may be particularly trueexample, in lightSeptember of a decision from2021, the U.S. Court of Appeals for the 11th Circuit in September 2021. In Catalyst Pharms, Inc. v. Becerra, or Catalyst, that court held that, for the purpose of determining the scope of orphan drug exclusivity, the term “same disease or condition” in the statute means the designated “rare disease or condition” and could not be interpreted by the FDA to mean the “indication or use.” Thus, the court concluded, orphan drug exclusivity applies to the entire designated disease or condition rather than the approved “indication or use.” Although there have been legislative proposals to overrule this decision, they have not been enacted into law. On January 23, 2023, the FDA announced that,Subsequently, in mattersanother beyond the scope of the Catalyst court order, the FDA will continue to apply its existing regulations tying orphan-drug exclusivity to the uses or indications for which the orphan drug is approved. More recently, however, on February 14, 2025,case, a federal district court in Washington, D.C., fully embracedfollowed the reasoning of the Catalyst11th Circuit decision inand anotherthat decision challenging the scope of orphan drug exclusivity. On April 17, 2025, the FDAwas appealed this decision to the U.S. Court of Appeals for the D.C. Circuit. TheOn implicationsFebruary 3, 2026, the Consolidated Appropriations Act of this2026 decision,was enacted into law. It overruled these court decisions and its impact oncodified the FDA’s implementationlongstanding interpretation of the Orphanscope Drugof Act,orphan drug exclusivity to apply to “the same drug for the same approved use or indication within such designated rare disease or condition.” This change, which applies retroactively, expressly authorizes the FDA to approve multiple versions of the same orphan drug for different sub-indications and subpopulations, such as adult and pediatric patients or multiple variations of the same disease that are unclearcaused atby thisdifferent point.genetic variants.
On June 6, 2023, Merck & Co., or Merck, filed a lawsuit against the HHS and CMS asserting that, among other things, the IRA’s Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the Constitution. Subsequently, a number of other parties, including the U.S. Chamber of Commerce, Bristol Myers Squibb Company, the PhRMA, Astellas, Novo Nordisk, Janssen Pharmaceuticals, Novartis, AstraZeneca and Boehringer Ingelheim, also filed lawsuits in various courts with similar constitutional claims against the HHS and CMS. TheEvery HHScourt that has generallythus wonfar considered substantive challenges to the substantiveMedicare disputesdrug inprice thesenegotiation cases,program orhas succeededruled inagainst gettingthe claimspharmaceutical dismissedindustry, fordismissing lackboth ofconstitutional standing.and statutory arguments. We expect that current or future litigation involving provisions of the IRA will have unpredictable and uncertain results on the implementation and impact of the IRA on the biotechnology industry generally, as well as our business and current or future products.
In 2025, the U.S. government initiated a series of tariff-related actions against U.S. trading partners, which included a number of reciprocal and country-specific tariffs under the International Emergency Economic Powers Act, or the IEEPA. In February 2026, the U.S. Supreme Court held that the IEEPA does not authorize the President to impose tariffs, invalidating both the “reciprocal” tariffs and certain country-specific tariffs. The President subsequently invoked Section 122 of the Trade Act of 19741974, or the Trade Act, to impose a 10% tariff, which could be raised to 15%, on nearly all foreign imports. The tariffs imposed under Section 122 are temporary and valid for 150 days without congressional approval. MultipleOn statesMay have7, challenged2026, the U.S. Court of International Trade ruled that these tariffs inwere court.Theunlawful and issued a permanent injunction for certain named private party plaintiffs and the State of Washington. The U.S. Tradegovernment Representativeappealed concurrentlyto initiatedthe twoU.S. investigationsCourt underof SectionAppeals 301for the Federal Circuit and, on June 11, 2026, the Federal Circuit stayed enforcement of the Tradelower Actcourt’s ofpermanent 1974,injunction whichpending mayfurther also result in additional tariffs.appeals.
In addition, the U.S. Trade Representative is currently conducting two investigations under Section 301 of the Trade Act, which may also result in additional tariffs. In June 2026, in one such investigation, it proposed additional tariffs of 10% to 12.5% on products of 60 economies determined to have failed to impose and effectively enforce a prohibition on the importation of goods produced with forced labor. These proposed tariffs remain subject to an ongoing notice-and-comment process and have not yet taken effect, and the second investigation into structural excess capacity and production in manufacturing sectors remains ongoing.
Separately, in 2025, the Department of Commerce initiated an investigation under Section 232 of the Trade Expansion Act of 1962 into the impact on U.S. national security of the imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. On September 25, 2025, the U.S. administration announced that, beginning October 1, 2025, all branded or patented drugs imported in the U.S. would face a 100% tariff. At the same time, the administration indicated that these tariffs could be avoided by building pharmaceutical manufacturing facilities in the U.S. Thereafter, the administration delayed the October 1, 2025 effective date of the tariffs on branded or patented pharmaceutical products announcing that the administration had now “begun preparing” tariffs on manufacturers that do not build in the U.S. or enter into a most-favored-nation drug pricing agreement with the administration. Significant uncertainty surrounding trade policy and tariff activity continues.
On April 2, 2026, the administration issued a proclamation invoking Section 232 of the Trade Expansion Act of 1962 to impose tariffs on imports of patented pharmaceuticals, biologics, and associated ingredients into the U.S. Specifically, beginning July 31, 2026, a 100% tariff will apply to pharmaceutical articles classified in certain 10-digit harmonized tariff, or HTS, codes that are subject to a valid, unexpired U.S. patent and are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book, or are listed in the FDA’s Lists of Licensed Biological Products, or the Purple Book, unless a relevant exemption applies. The 100% tariff also applies to active pharmaceutical ingredients, or APIs, and key starting materials for such articles. For companies like ours that are not listed in the annexes to the proclamation (i.e., those that have not concluded qualifying onshoring plans and MFN pharmaceutical pricing agreements with the U.S. government), the Section 232 tariffs will be effective on September 29, 2026. Preferential tariff rates are provided for imports of covered pharmaceuticals from Japan, the EU, Korea, Switzerland, Lichtenstein and the U.K. Certain categories of products are exempt from these tariffs, including, but not limited to, generic pharmaceuticals and biosimilars; specified U.S.-origin pharmaceutical products; and products classified in certain HTS codes, listed in Annex IV of the proclamation. DrugsOther products likely to be exempt from the tariffs include drugs and associated ingredients for all approved indications that are designated as orphan pursuant to the Orphan Drug Act; drugs for certain specific uses, including nuclear medicines; plasma-derived therapies; fertility treatments; cell and gene therapies; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological, and nuclear threats; animal health; and other specialty pharmaceutical products to be later identified by the Secretary of Commerce are also likely to be exempt from the tariffs.Commerce.
We depend on our information technology systems and those of our third-party service providers, and any failure of these systems could harm our business. Security breaches, loss of data, inability to access systems, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability or competitive or reputational harm, which could adversely affect our business, results of operations and financial condition. In addition, artificial intelligence, or AI, presents emerging risks and challenges that may impact our business.
The risk of a security breach or disruption or data loss, particularly through cyber-attacks or cyber intrusion, including by computer hackers, supply chain attacks, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Additionally, attackers may use artificial intelligenceAI and machine learning to launch more automated, targeted and coordinated attacks against targets. In addition, the prevalent use of mobile devices that access confidential information increases the risk of lost or stolen devices, security incidents and data security breaches, which could lead to the loss of confidential information or other intellectual property. We also may face increased risks of a security breach or disruption due to our reliance on internet technology and the number of our employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities. The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service, negative publicity and other harm to our business and our competitive position. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs.
We also face additional emerging risks associated with the use of generative AI and related technologies, which we have implemented, and may further expand, into our operations. The development and use of AI, combined with an uncertain regulatory environment, introduce risks and challenges that may result in reputational harm, liability, or other adverse consequences to our business operations. In addition, we may face competitive risks if we fail to adopt AI or other machine learning technologies in a timely fashion. AI algorithms may be flawed, datasets may be insufficient or biased and overreliance on AI or dependence on a specific model or vendor may limit our flexibility, increase costs, or expose us to operational risks if the AI provider modifies or discontinues its services or increases its costs. AI use could lead to noncompliance with applicable laws and regulations, threats to intellectual property rights, including the leakage of our proprietary information and the risk that AI-generated outputs may infringe third-party intellectual property rights. In addition, the providers of these AI tools may not meet existing or future regulatory or industry standards with respect to privacy and data protection. All of these risks also apply to our vendors who use AI and who may incorporate AI tools into their offerings without disclosing this use to us. If we, our vendors, or our third-party partners experience an actual or perceived breach or other privacy or security incident because of the use of AI, we may lose valuable intellectual property and confidential information, and our reputation and the public perception of the effectiveness of our security measures could be harmed. Further, bad actors around the world use increasingly sophisticated methods, including AI, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property. Additionally, several states have passed laws to regulate the use of AI and the regulatory environment is rapidly evolving at the state, federal, and international levels, which creates potential compliance and enforcement risk. Any of these developments in AI could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.
We also face emerging risks associated with the use of generative artificial intelligence and related technologies, including algorithmic error, vendor dependency, potential infringement of third-party intellectual property rights through agent-generated outputs, and an uncertain and rapidly evolving regulatory environment at the state, federal, and international levels, any of which could adversely impact our business, results of operations and financial condition.
our recently effectedthe reverse stock split of our common stock, which became effective March 13, 2026;
As of DecemberJune 31,30, 2025,2026, our executive officers, directors, holders of 5% or more of our common stock and their respective affiliates beneficially owned shares in the aggregate representing a majority of our outstanding common stock. As a result of their share ownership, these stockholders, if they act together, would have the ability to influence our management and policies and would be able to significantly affect the outcome of matters requiring stockholder approval, such as elections of directors, amendments of our organizational documents or approvals of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that our stockholders may feel are in their best interest.
Income, sales, use or other tax laws, statutes, rules, or regulations could be enacted or amended at any time, which could affect our business or financial condition, including causing potentially adverse impacts to our effective tax rate, tax liabilities, and cash tax obligations. For example, the IRA was signed into law in August 2022 and OBBBA was signed into law in July 2025. The IRA introduced new tax provisions, including a one percent excise tax imposed on certain stock repurchases by publicly traded companies.
Income, sales, use or other tax laws, statutes, rules, or regulations could be enacted or amended at any time, which could affect our business or financial condition, including causing potentially adverse impacts to our effective tax rate, tax liabilities, and cash tax obligations. For example, the IRA was signed into law in August 2022 and OBBBA was signed into law in July 2025. The IRA introduced new tax provisions, including a one percent excise tax imposed on certain stock repurchases by publicly traded companies. The one percent excise tax generally applies to any acquisition of stock by the publicly traded company (or certain of its affiliates) from a stockholder of the company in exchange for money or other property (other than stock of the company itself), subject to certain exceptions. Thus, the excise tax could apply to certain transactions that are not traditional stock repurchases. The OBBBA contains numerous tax provisions that may significantly affect our business or financial condition. The recent changes under the OBBBA include tax rate extensions, changes to the business interest deduction limitation, the election to either fully deduct or continue to capitalize and amortize domestic research and development expenditures (in contrast to the continued capitalization and amortization of foreign research and development expenditures), changes to the bonus depreciation deduction rules, and changes to the international tax framework. Regulatory guidance under the OBBBA and other tax-related legislation is and continues to be forthcoming, and we will utilize such guidance to analyze the impact of such legislation on our business and financial condition. In addition, it is uncertain if and to what extent various states will conform to federal tax legislation.
Management's Discussion & Analysis (MD&A)
New heading “XTX501: bispecific PD-1 / masked IL-2”
New heading “Masked T Cell Engager Programs”
New heading “Efarindodekin alfa: masked IL-12”
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Collaboration and License Revenue”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Change in Fair Value of Common Stock Warrant Liabilities”
Removed heading “Other Income, Net”
Removed heading “Other Income, Net”
Removed heading “Other Income, Net”
Largest changes
“XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational backbone therapy for solid tumors, including in combination with other agents. XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. We received clearance from the U.S. …”see in full comparison
Full comparison: every changed paragraph (64)
We are a clinical-stage biotechnology company discovering and developing masked immuno-oncology, or I-O, therapies with the goal of significantly improving outcomes for people living with cancer. Leveraging our clinically-validated masking technology and capabilities, we are developing I-O therapies designed to selectively activate within the tumor microenvironment to achieve durable efficacy without the severe side effects associated with systemically active I-O agents. Our integrated biology and protein engineering approach enables us to design and develop highly potent, masked biologics that are activated, or unmasked, by tumor-specific proteases within the tumor microenvironment. We are currently advancing multiple programs in preclinical and clinical development, including: XTX501, a bispecific PD-1 / masked multi-specifics,IL-2; multi-specific masked T cell engagers, or TCEs; and ourefarindodekin alfa, a masked IL-12. Our clinically-validated masking technology has enabled us to establish top-tier strategic partnerships, including with AbbVie Group Holdings Limited, or AbbVie, and Gilead Sciences, Inc., or Gilead.
XTX501: bispecific PD-1 / masked IL-2
XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational backbone therapy for solid tumors, including in combination with other agents. XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. We received clearance from the U.S. Food and Drug Administration, or FDA, for our investigational new drug application, or IND, to proceed to a first-in-human, multi-center, open-label Phase 1/2 clinical trial for XTX501. We expect to initiate dosing in the Phase 1 portion of the trial in patients with metastatic non-small cell lung cancer, or NSCLC, and select advanced solid tumors in the second half of 2026, and we plan to report initial Phase 1 data in patients with metastatic NSCLC in the second half of 2027.
Masked T Cell Engager Programs
We are leveraging our proprietary, clinically-validated masking technology and modular TCE architectures to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie. Our masked TCEs are designed with a masked CD3 targeting domain and one or more tumor-associated antigen, or TAA, binding domains as part of the core molecule design. In addition, our modular architecture enables the incorporation of a co-stimulatory domain designed to further enhance potency and durability of T cell response, as well as the potential to mask the TAA binding domain(s) and/or mask the co-stimulatory signaling domain. Upon tumor-selective activation, our TCE molecules are designed to release a potent, short half-life TCE in the tumor microenvironment.
We are advancing IND-enabling studies for a potential first-in-class masked TCE program targeting CLDN18.2 and a potential first-in-class multi-specific, masked TCE program targeting PSMA and STEAP1 with built-in co-stimulatory signaling. CLDN18.2 is a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal), and PSMA and STEAP1 are TAAs expressed in prostate cancer. We plan to submit INDs for our CLDN18.2 and PSMA+STEAP1 programs in the second half of 2027.
Efarindodekin alfa: masked IL-12
We are evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors under our license agreement with Gilead and expect to deliver an option data package to Gilead in the first half of 2027.
To date, we have financed our operations primarily from proceeds raised through private placements of equity securities,securities; sales of common stock in our initial public offering, or IPO, and through “at-the-market” offerings; the sale of prefunded warrants in our June 2025 and February 2026 follow-on offerings; the exercise of certain common stock warrants issued in connection with our June 2025 follow-on offering; development event payments under our co-funded clinical trial collaboration with F. Hoffmann-La Roche Ltd., or Roche; and upfront payments and milestone payments under our collaboration and license agreements with AbbVie and Gilead. All of our programs are in early clinical or preclinical development. As a result, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for at least the next several years, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates, if approved. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve profitability. Even if we are able to generate revenue from product sales, we may not become profitable.
Since inception, we have incurred significant operating losses, including net losses of $9.5$15.9 million and $13.3$29.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, and a net loss of $35.0 million for the year ended December 31, 2025. As of MarchJune 31,30, 2026, we had an accumulated deficit of $428.3$434.7 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future, particularly to the extent we:
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of MarchJune 31,30, 2026, we had cash and cash equivalents of $150.3$136.0 million. In the second quarter of 2026, we achieved a $6.0 million development milestone related to the collaboration agreement with AbbVie.AbbVie, which we received in the third quarter of 2026. Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of MarchJune 31,30, 2026, together with the $6.0 million development milestone achieved under the AbbVie collaboration in the second quarter of 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into earlythe first quarter of 2028. This estimate excludes any potential additional milestone payments, option-related fees or other contingent payments under our existing collaboration and partnership agreements with AbbVie and Gilead and excludes the potential receipt of up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.price and any potential additional milestone payments, option-related fees or other contingent payments under our collaboration and license agreements with AbbVie and Gilead, including up to $31.0 million in near-term milestones and option extension fees that could be achieved under the AbbVie collaboration through the first half of 2027.
Revenue
We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific deliverables using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our condensed consolidated balance sheets as prepaid expenses or accrued research and development expenses. We record cost-sharing payments under our clinical trial collaboration with Roche as a reduction of research and development costs upon the achievement of each study development event specified in the clinical supply agreement. NonrefundableNon-refundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized as assets, even when there is no alternative future use for the research and development. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
our ability to successfully complete clinical trials with safety, potency and purity profiles that are satisfactory to the U.S. Food and Drug Administration, or the FDA,FDA or any comparable foreign regulatory authority;
Other Income, Net
The change in fair value of common stock warrant liabilities consists of the changegain inor loss recorded upon the fairrevaluation valueat each reporting period of the common stock warrant liabilities fromin Decemberconnection 31,with the June 2025 tofollow-on March 31, 2026.offering.
Other income (expense), net consists primarily of interest income earned from our cash and cash equivalents, and for the three and six months ended June 30, 2025 also consists of the portion of the issuance costs we incurred in connection with the June 2025 follow-on offering, which were allocated to the common stock warrant liabilities.
Other Income, Net
Other income, net consists primarily of interest income earned from our cash and cash equivalents.
Comparison of the three months ended MarchJune 31,30, 2026 and 2025
The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):
Collaboration and license revenue increased by $9.7$10.6 million from $2.9$8.1 million for the three months ended MarchJune 31,30, 2025 to $12.6$18.7 million for the three months ended MarchJune 31,30, 2026. The increase was due to an increase in collaboration and license revenue recognized under our collaboration and license agreements with AbbVie and Gilead.
The following table summarizes our research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):
Research and development expenses increaseddecreased by $11.6$0.8 million from $8.3$15.3 million for the three months ended MarchJune 31,30, 2025 to $19.8$14.6 million for the three months ended MarchJune 31,30, 2026. The changes in research and development expenses were primarily due to the following:
XTX501 costs increased by $5.7 million, primarily driven by an increase in manufacturing activities related to IND-enabling studies and preclinical development activities;
other early programs and indirect research and development costs increased by $2.8$1.7 million, primarily driven by an increase in external expenses related to preclinical research and development activities, including costs related to our masked TCE programs targeting CLDN18.2 program,and prostrate programPSMA+STEAP1 and our AbbVie collaboration;
vilastobart costs increased by $1.3 million, primarily driven by a $2.0 million cost-sharing payment earned under our Roche clinical collaboration during the three months ended March 31, 2025, which we recorded as a reduction in research and development expenses and for which there was no corresponding cost-sharing payment during the three months ended March 31, 2026, partially offset by a $0.7 million decrease in clinical development activities related to our ongoing Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab;
personnel-related costs increased by $1.4$0.8 million, primarily driven by a $1.0$0.6 million increase in salaries, bonuses and benefits due to higher research and development headcount,headcount and a $0.4$0.2 million increase in stock-based compensation; and efarindodekin alfa costs increased by $0.4 million, primarily driven by an increase in clinical development activities related to our ongoing our Phase 2 clinical trial evaluating efarindodekin alfa as a monotherapy in patients with certain advanced solid tumors.
efarindodekin alfa costs decreased by $0.2 million, primarily driven by a decrease in clinical development activities related to our ongoing Phase 2 clinical trial;
XTX501 costs decreased by $0.3 million, primarily driven by a $0.3 million decrease in manufacturing activities related to IND-enabling studies and a $0.2 million decrease in preclinical development activities, partially offset by a $0.2 million increase in clinical trial startup activities related to our Phase 1/2 clinical trial for XTX501; and vilastobart costs decreased by $2.8 million, primarily driven by a decrease in clinical development activities related to our Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab.
The following table summarizes our general and administrative expenses for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):
General and administrative expenses decreasedincreased by $1.6$0.5 million from $8.5$7.1 million for the three months ended MarchJune 31,30, 2025 to $6.9$7.6 million for the three months ended MarchJune 31,30, 2026. The changes in general and administrative expenses were primarily due to the following:
personnel-related costs decreasedincreased by $0.3 million, primarily driven by an increase in salary, severance and recruiting costs, partially offset by a decrease in severance costs and discretionary bonus costs; and professional and consulting fees decreasedincreased by $1.2$0.2 million, primarily driven by aan decreaseincrease in legal fees and other professional costs.
The change in fair value of common stock warrant liabilities for the three months ended MarchJune 31,30, 2026 was due to a gainloss of $3.3$3.9 million dueresulting tofrom the decreaseincrease in the fair value of the common stock warrant liabilities between DecemberMarch 31, 20252026 and MarchJune 31,30, 2026, which was primarily driven by aan, decreaseincrease in the price per share of our common stock.
Other Income, Net
Other income,income (expense), net, increased by $0.7$2.5 million from $0.6other expense of $1.4 million for the three months ended MarchJune 31,30, 2025 to $1.3other income of $1.1 million for the three months ended MarchJune 31,30, 2026. The increase in other income,income (expense), net was primarily due to an increase in interest income due to a higher average cash balance.balance and the $2.3 million in issuance costs we incurred in connection with the June 2025 follow-on offering, which were allocated to the common stock warrant liabilities, for which there was no comparable cost for the three months ended June 30, 2026.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Collaboration and License Revenue
Collaboration and license revenue increased by $20.3 million from $11.0 million for the six months ended June 30, 2025 to $31.3 million for the six months ended June 30, 2026. The increase was due to an increase in collaboration and license revenue recognized under our collaboration and license agreements with AbbVie and Gilead.
Research and Development Expenses
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands):
Research and development expenses increased by $10.8 million from $23.6 million for the six months ended June 30, 2025 to $34.4 million for the six months ended June 30, 2026. The changes in research and development expenses were primarily due to the following:
XTX501 costs increased by $5.4 million, primarily driven by a $2.6 million increase in manufacturing activities related to IND-enabling studies, a $1.6 million increase related to clinical trial startup activities for our Phase 1/2 clinical trial for XTX501 and a $1.0 million increase in preclinical development activities;
other early programs and indirect research and development costs increased by $4.5 million, primarily driven by an increase in external expenses related to preclinical research and development activities, including costs related to our masked TCE programs targeting CLDN18.2 and PSMA+STEAP1 and our AbbVie collaboration;
personnel-related costs increased by $2.2 million, primarily driven by a $1.6 million increase in salaries, bonuses and benefits due to higher research and development headcount and a $0.6 million increase in stock-based compensation;
efarindodekin alfa costs increased by $0.2 million, primarily driven by an increase in clinical development activities related to our ongoing Phase 2 clinical trial; and vilastobart costs decreased by $1.5 million, primarily driven by a decrease in clinical development activities related to our Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025 (in thousands):
General and administrative expenses decreased by $1.1 million from $15.6 million for the six months ended June 30, 2025 to $14.6 million for the six months ended June 30, 2026. The changes in general and administrative expenses were primarily due to a decrease of $1.0 million in legal fees and other professional costs.
Change in Fair Value of Common Stock Warrant Liabilities
The change in fair value of common stock warrant liabilities for the six months ended June 30, 2026 was due to a loss of $0.6 million resulting from the increase in the fair value of the common stock warrant liabilities between December 31, 2025 and June 30, 2026, which was primarily driven by an increase in the price per share of our common stock.
Other income (expense), net, increased by $3.2 million from other expense of $0.8 million for the six months ended June 30, 2025 to other income of $2.3 million for the six months ended June 30, 2026. The increase in other income (expense), net was primarily due to an increase in interest income due to a higher average cash balance, partially offset by the $2.3 million in issuance costs we incurred in connection with the June 2025 follow-on offering, which were allocated to the common stock warrant liabilities, for which there was no comparable cost for the three months ended June 30, 2026.
Since our inception, we have incurred significant operating losses and negative cash flows from operations. We have not yet commercialized any of our product candidates, which are in preclinical or early clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. To date, we have financed our operations primarily from proceeds raised through private placements of equity securities; sales of common stock in our IPO,IPO and through “at-the-market” offerings; the sale of prefunded warrants in our June 2025 and February 2026 follow-on offerings; the exercise of certain common stock warrants issued in connection with our June 2025 follow-on offering; development event payments under our co-funded clinical trial collaboration with Roche for vilastobart; and upfront and milestone payments under our collaboration and license agreements with AbbVie and Gilead. All of our programs are in early clinical or preclinical development. As a result, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for at least the next several years, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates, if approved. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve profitability. Even if we are able to generate revenue from product sales, we may not become profitable.
In May 2026, we filed a universal shelf registration statement on Form S-3 with the SEC to register for sale up to $250.0 million of our common stock, preferred stock, debt securities, units and warrants, which we may issue and sell from time to time in one or more offerings, which became effective on May 29, 2026 (333-295785), or the 2026 Form S-3. In May 2026, we filed a prospectus supplement to our prospectus in the 2026 Form S-3 to cover the offering, issuance and sale by us of up to a maximum of $14.5 million of our common stock that may be issued and sold from time to time under our sales agreement with Leerink.
During the three months ended June 30, 2026, we issued and sold 592,300 shares of our common stock pursuant to the sales agreement with Leerink at a weighted average price of $7.76 per share for aggregate gross proceeds of $4.6 million, before deducting underwriting discounts and commissions and any offering expenses.
During the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities of $22.3$41.1 million was primarily driven by net changes in operating assets and liabilities of $12.1$30.3 million,million and our net loss of $9.5$15.9 million, partially offset by $3.8 million andof stock-based compensation expense, the $3.3$0.6 million gainloss recorded on the change in fair value of our common stock warrant liabilities, partially offset by $2.2 million of stock-based compensation expenseliabilities and $0.3$0.6 million of depreciation and amortization expense.
During the threesix months ended MarchJune 31,30, 2025, net cash provided by operating activities of $29.0$14.5 million was primarily driven by net changes in operating assets and liabilities of $40.2$37.5 million, which includes the $49.1 million recorded as deferred revenue in connection with our collaboration, license and option agreement and stock purchase agreement with AbbVie, and net non-cash expenses of $2.0$6.1 million, partially offset by our net loss of $13.3$29.1 million.
During the threesix months ended MarchJune 31,30, 2026 and 2025, net cash used in investing activities consisted of purchases of property and equipment.
During the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities of $35.7$40.2 million primarily consisted of proceeds from the sale of prefunded warrants through a follow-on offering.offering and proceeds from the sale and issuance of common stock through our ATM program.
XLO insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding XLO (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 64,153 | $614.6K | 0.0% | Added 29% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 25,950 | $248.6K | 0.0% | New position |
| Two Sigma Investments | 2026-06-30 | 14,544 | $139.3K | 0.0% | New position |